Adapter for a medical container, medical container including an adapter, and method for manufacturing the adapter - Patents.com

Abstract

The adapter (1) comprises a proximal portion (2) configured to be secured onto a distal tip (102) of a medical container (100) and a distal portion (4) configured to receive a connector to establish fluid communication between the distal tip (102) of the medical container (100) and the connector, the distal portion (4) comprising a window (60) extending through a side wall (6) of the adapter. The adapter further comprises an indicator (8) movable between a first position and a second position, the indicator (8) extending outward relative to the first position. The adapter further comprises an indicator (8) movable between a first position and a second position, the indicator (8) extending outward relative to the first position. The indicator (8) comprises a blocking means configured to block movement of the indicator (8) from said first position to a second position, and a cam portion (82) configured to be pushed outward by the connector when the connector reaches a predetermined position within the connector, thereby unblocking and pushing the indicator (8) to the second position to provide a visual and tactile indication to the end user that the connection between the connector and the adapter (1) has been completed.

Description

[Technical field]

[0001] The present invention relates to an adapter for attaching a medical container to a connector, a medical container including said adapter, and a method for manufacturing said adapter.

[0002] In this application, the distal end of a component or device is understood to mean the end furthest from the user's hand, and the proximal end is understood to mean the end closest to the user's hand. Similarly, in this application, a "distal direction" is understood to mean, with respect to an adapter or medical container of the present invention, the direction of injection, and a "proximal direction" is understood to mean the direction opposite to said injection direction, i.e., the direction toward the user's hand holding the container with respect to an injection operation. [Background technology]

[0003] Essentially, medical containers, such as syringes, are preferably made of glass due to its high chemical passivation, low gas permeability and high transparency, which allows for long-term storage and easy inspection.

[0004] A medical container typically comprises a container forming a reservoir for containing a medical product. The container has a distal end in the form of a longitudinal tip that defines an axial passageway through which the medicinal product is expelled from the container. However, this longitudinal tip does not by itself allow parenteral administration, but must be provided with either a staked needle or an adapter that allows a syringe to be connected to a connector such as a needle hub. This connector is typically threaded onto the adapter and engages the distal end of the container to establish a fluid pathway between the reservoir and said connector.

[0005] It is important that the connector is properly threaded onto the adapter. The end user must apply sufficient torque when threading the connector onto the adapter to obtain a proper fitting of the connector onto the distal end of the container. Not threading the connector far enough onto the adapter can result in the connector popping off, leakage when transferring fluid between the container and the connector, or leakage between the connector and the tip of the syringe. Alternatively, threading the connector too far onto the adapter can lead to rotation or tilting of the adapter.

[0006] Therefore, there is a need for a medical container that provides an indication to the end user that the connector is properly threaded onto the adapter, thus increasing the end user's confidence during the connection and injection steps. Summary of the Invention

[0007] An aspect of the present invention is an adapter for connecting a medical container to a connector, comprising: a proximal portion configured to be secured to a distal tip of a medical container; a distal portion configured to receive the connector to establish fluid communication between the distal tip of the medical container and the connector, the distal portion comprising a window extending through a side wall of the adapter; an indicator movable between a first position and a second position and extending outwardly relative to the first position, blocking means configured to block movement of the indicator from the first position to the second position; a cam portion protruding from a window in the adapter in the first position, the cam portion configured to be pushed outward by the connector when the connector reaches a predetermined position in the adapter, thereby unblocking and pushing an indicator to a second position to provide a visual indication to an end user that a connection between the connector and the adapter is complete; an indicator comprising: It is an adapter comprising:

[0008] The adapter of the present invention therefore allows the end user to know when the connection of the connector to the adapter should be stopped in order to avoid under- or over-fit connections and thus the risk of leakage or connector blowout during fluid transfer. Indeed, the indicator is arranged at a predefined position in the adapter, said position corresponding to a leakage limit. Thus, the indicator is pushed into the second position only when the connector reaches this leakage limit. Furthermore, the blocking means prevents any inadvertent opening of the indicator before a safe connection of the connector in the adapter, thus avoiding misleading the end user into thinking that the connection is finished. The cam portion urging the indicator to the blocking means further provides an increasing screwing torque until the blocking means releases the indicator which moves suddenly to the second position. As a result, this may give an additional tactile indication that the connection is finished. Preferably, the indication that the connection is finished is both visual and tactile.

[0009] The first position may advantageously be a plane tangent to the outer surface of the indicator and to the outer wall of the adapter, which may be at an angle of 5° or less, preferably 2° or less, more preferably about 0°.

[0010] The second position may advantageously be a plane tangent to the outer surface of the indicator and to the outer wall of the adapter, the plane being at an angle of more than 10°, preferably more than 20°, more preferably more than 30°.

[0011] The angular difference between the first and second positions is advantageously greater than or equal to 10°, preferably greater than or equal to 20°, and more preferably greater than or equal to 30°.

[0012] The adapter of the invention preferably comprises an internal thread so that the connector is screwed onto the adapter. Advantageously, the connector comprises at least two wings which may be diametrically opposed to one another.

[0013] In one embodiment, the blocking means comprises a protrusion configured to abut against an inner surface of the adapter side wall or against a gripping rib of the adapter.

[0014] The cam portion may include a sloped wall configured to gradually increase the pressure exerted by the connector on said cam portion as the connector is screwed onto the adapter, which may provide a tactile indication to the end user.

[0015] In one embodiment, the window opens at the thread root of the internal threads of the adapter.

[0016] The cam portion may extend axially across most of the thread root width, which ensures that the connecting element of the connector, whatever the connecting element may be, abuts the cam portion.

[0017] In one embodiment, the indicator is rotatably connected to a side wall of the adapter.

[0018] Thus, when the connection is secured the indicator opens like a flap.

[0019] The indicator may have a different color than the rest of the adapter.

[0020] This enhances the visual display presented to the end user.

[0021] The adapter may be provided with a display surface that is hidden from an end user in a first position and is visible to the end user in a second position, said display surface having a different color than the remainder of the adapter, this color difference improving the visual indication provided to the end user.

[0022] The indicator may have an outer wall that extends axially over the window, preferably along the entire length of the adapter. This long outer wall makes the indicator easily visible to the end user, thus improving the visual indication.

[0023] In a first embodiment, the blocking means comprises a resilient leg configured to be deformed and then released when the indicator is pushed from the first position to the second position, thereby emitting a sound. For example, said sound may be a "click".

[0024] In said first embodiment, the blocking means may alternatively or complementary comprise a protrusion arranged to abut against a gripping rib of the adapter.

[0025] In a first embodiment, the indicator is attached to the adapter, and preferably clipped to the adapter.

[0026] Thus, the indicator and the adapter may be two different parts that are assembled together. The indicator may comprise two ridges or two recesses and the window comprises two recesses or two ridges configured to receive said two ridges or said recesses to form a pivot connection.

[0027] In a second embodiment, the indicator and the adapter are comprised of a single piece.

[0028] This limits the manufacturing cost and number of manufacturing steps since this embodiment does not require any assembly steps.

[0029] In this second embodiment, the indicator is connected to the sidewall by a resilient arm, the resilient arm configured to bias the indicator toward the second position.

[0030] This allows the indicator to be easily moved to the second position, and further, the resilient arm can be configured such that when the indicator reaches the second position, the indicator is substantially perpendicular to the adapter side wall, so that this second position is visible to the user.

[0031] In this second embodiment, the blocking means comprises a protrusion configured to abut an inner surface of the adapter side wall.

[0032] Another aspect of the invention is a medical container comprising a distal tip and the adapter described above, the adapter being attached to the distal tip of the medical container.

[0033] In one embodiment, the medical container comprises a cap having a mating portion engaged with an adapter, the mating portion configured to secure the cap to the adapter without abutting a cam portion of the indicator.

[0034] Another aspect of the present invention is a method of manufacturing the adapter described above, said method comprising the steps of: forming an indicator by injection molding; and forming the adapter by injection molding.

[0035] In one embodiment, the method further comprises assembling the indicator and the adapter.

[0036] In an alternative embodiment, the steps of forming the indicator and forming the adapter are a single step in which the indicator and the adapter are entirely formed in the same injection mold.

[0037] In the embodiment, the indicator is injection molded to be in the second position.

[0038] As a result, the normal shape of the indicator is when the indicator is in the second position. The first position therefore corresponds to an unstable position: the indicator has a tendency to return to the second position and is only prevented by the blocking means until the pressure exerted by the connector on the cam portion overcomes the action of the blocking means and thereby the indicator is free to return to its normal shape, i.e. to the second position. [Brief description of the drawings]

[0039] The invention and the advantages arising therefrom will become apparent from the detailed description given below with reference to the accompanying drawings, in which: [Figure 1] FIG. 1 is a perspective view of an adapter according to a first embodiment of the present invention with an indicator in a first position. [Diagram 2] FIG. 2 is a perspective view of an adapter according to a first embodiment of the invention with an indicator in a second position. [Diagram 3] FIG. 3 is a top view of an adapter according to a first embodiment of the invention with an indicator in a first position. [Figure 4] FIG. 4 is a perspective view of an adapter according to a second embodiment of the present invention with the indicator in a first position. [Diagram 5] FIG. 5 is a perspective view of an adapter according to a second embodiment of the present invention with the indicator in a first position. [Figure 6] FIG. 6 is a perspective view of an adapter according to a second embodiment of the present invention with the indicator in a second position. [Figure 7] FIG. 7 is a top view of an adapter according to a second embodiment of the present invention with the indicator in a first position. [Figure 8] FIG. 8 is a cross-sectional view of a medical container according to one embodiment of the present invention. [Figure 9] FIG. 9 is an exploded view of the adapter according to the first embodiment of the present invention. [Figure 10] FIG. 10 is an exploded view of an adapter according to a second embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] With reference to Fig. 1, an adapter 1 according to an embodiment of the present invention is shown. With reference to Fig. 8, the adapter 1 is intended to be attached to a distal tip 102 of a medical container 100, more precisely to the outer surface of said distal tip 102. Said outer surface may be cylindrical or tapered towards the distal end. The adapter 1 makes it possible to connect a connector such as a needle hub 200 to this distal tip 102.

[0041] The adapter 1 comprises a proximal portion 2, which may be in the form of an attachment ring configured to be fixed to the medical container 100, and a distal portion 4, which may be in the form of a connecting ring configured to receive a connector to establish a reliable fluid communication between the passage of the distal tip 102 and said connector. The distal portion 4 thus comprises a connecting means, such as an internal thread 40, configured to engage with a corresponding connecting means, such as wings 202 of a needle hub 200, to secure the connector to the distal tip 102. Advantageously, a connector, such as a needle hub 200, received in the adapter 1 comprises two diametrically opposed wings 202. As shown in FIG. 8, the internal thread 40 has a thread 40a and a thread root 40b. This connecting means may alternatively comprise a bayonet element, a snap element, or a press-fit element.

[0042] 9 and 10, the adapter 1 has a side wall 6 with a window 60. The window 60 defines a through opening extending from an outer surface to an inner surface 62 of said side wall 6. The window 60 may be arranged along the path of the connection means of the connector. As shown in FIG. 9, the window 60 may preferably open at the thread root 40b of the internal thread 40. However, the window 60 may open at another location of the adapter 1, such as at the thread 40a of the internal thread 40. The window 60 may extend parallel to the internal thread 40, i.e., longitudinally to define an angle with the longitudinal axis A of the adapter 1, or with a transverse plane perpendicular to said longitudinal axis A. The side wall 6 of the adapter 1 may include an axial gripping rib 64. The window 60 may be arranged through a portion of the side wall 6 located between two adjacent gripping ribs 64.

[0043] The adapter 1 further comprises an indicator 8 configured to indicate to an end user that the connection between the connector and the adapter 1 is complete. Specifically, the indicator 8 is movable between a first position (FIGS. 1, 3-5, 7) in which the indicator 8 is adjacent or near the side wall 6 of the adapter 1, and a second position (FIGS. 2, 6, 10) in which the indicator 8 extends outward from the first position. In the first position, the indicator 8 may extend through the window 60. The first position of the indicator 8 relative to the adapter 1 may be a plane tangent to the outer surface of the indicator 8 and a plane tangent to the outer wall of the adapter 1 that is at an angle of 5° or less, preferably 2° or less, more preferably about 0°. The second position of the indicator 8 relative to the adapter 1 may be a plane tangent to the outer surface of the indicator 8 and a plane tangent to the outer wall of the adapter 1 that is at an angle of 10° or more. Preferably, the angle difference between the first position and the second position is advantageously 10° or more, preferably 20° or more, more preferably 30° or more, so that the end user can easily notice that the connection is complete.

[0044] The adapter 1 comprises blocking means configured to hold the indicator 8 in the first position unless the connection between the connector and the adapter 1 is complete, as will be explained in more detail below.

[0045] As shown in figures 3 and 7, the indicator 8 further comprises a cam portion 82 extending through the window 60 in the first position. The cam portion 82 is configured to be pushed outwardly, preferably radially outwardly, by the connector when the connector reaches a predetermined position in the adapter 1, thereby causing the insertion of the connector into the adapter 1, overcoming the action of the blocking means and pushing the indicator 8 to the second position. Said predetermined position is advantageously defined to be the leakage limit of the connector, as defined in ISO80369-7 (2016) (paragraphs 6.1 and 6.2). If the connector is not sufficiently connected to reach said position, leakage may occur. In contrast, if the connector is overconnected, the connector may break or be ejected from the adapter. It is noted that the indicator 8 is configured to be activated, i.e. moved to the second position, only when the connector reaches the leakage limit position. Thus, the indicator 8, more specifically the cam portion 82 of the indicator 8, is positioned in the adapter 1 such that the indicator 8 moves to the second position only when the connector reaches the predetermined position.

[0046] As seen in Figs. 3 and 7, the cam portion 82 projects inwardly from the inner 62 surface of the side wall 6 of the adapter 1 in the first position. The cam portion 82 is located in the path of the connector, more specifically in the path of the connecting means of the connector. For example, with reference to Fig. 9, the cam portion 82 is advantageously located in the thread root 40b of the inner thread in the first position. It is contemplated that the cam portion 82 may extend axially over a major portion of the width of the thread root 40b to ensure that the wings 202 of the needle hub 200 abut against the cam portion 82 of the indicator 8 when the connector reaches a predetermined position. The cam portion 82 may comprise an inclined wall 820 configured to gradually increase the pressure exerted by the connector on said cam portion 82 as the connector is screwed into the adapter 1. This inclined wall 820 may have a flat or concave abutment surface. The cam portion 82 and the action block means cause an increase in the screwing torque followed by a release, thereby providing the user with a further tactile indication that the connection is completed. The angled wall 820 is shaped such that the cam portion 82 is pushed outward by the connector, preferably radially outward, or alternatively in another direction, such as axially outward.

[0047] In a first embodiment, referring to FIG. 3, the indicator 8 comprises a sound emitting means, such as a resilient leg 84 configured to emit an audible sound when the indicator 8 moves from the first position to the second position, thereby providing the end user with an audible indication that the connection is complete. The resilient leg 84 may be configured to be deformed and then released when the indicator 8 is pushed from the first position to the second position, such that the resilient leg 84 emits a sound, preferably a click. The resilient leg 84 may extend between the cam portion 82 and the outer wall 80 of the indicator 8. The resilient leg 84 may have a free end 840 configured to abut against the side wall 6 of the adapter 1 in the first position, to be deformed when the connector abuts against the cam portion 82, and to return to a normal shape when the indicator 8 moves to the second position. In one embodiment, the blocking means comprises said resilient leg 84. The resilient leg 84 may be curved inwards in a normal shape, i.e. in a non-deformed state.

[0048] In the first embodiment illustrated in Fig. 3, the blocking means may alternatively or complementary comprise a protrusion 10 configured to abut the gripping rib 64. The protrusion 10 may be an axially extending rib or a shoulder. The protrusion 10 may have a rounded shape. As shown in Fig. 3, the protrusion 10 may be arranged on the outer wall 80 of the indicator 8, for example on its edge.

[0049] In a first embodiment illustrated in Figs. 1-3 and 9, the indicator 8 may have an outer wall 80 that may close the window 60 in a first position and open the window 60 in a second position. The outer wall 80 may possibly extend parallel to the side wall 6 of the adapter 1 in the first position and may be angled or perpendicular to said side wall 6 in the second position. The outer wall 80 may be flush with the side wall 6 or with the outer surface 640 of the gripping rib 64 in the first position, such that the indicator 8 advantageously does not protrude from the side wall 6 of the adapter 1 in said first position. As shown in Figs. 1, 2 and 9, the outer wall 80 of the adapter 1 is preferably larger than the window 60 and may extend axially over most of the length of the adapter 1, preferably along the entire length of the adapter 1, as seen in Figs. 1 and 2. This feature allows to have a better visual indication of whether the indicator 8 is in the first or second position.

[0050] In a second embodiment illustrated in Fig. 7, the blocking means may comprise a protrusion 10 configured to abut the inner surface 62 of the side wall 6. The protrusion 10 may be an axial rib. The protrusion 10 may have a rounded shape. As shown in Fig. 7, the protrusion 10 may be disposed on the cam portion 82 of the indicator 8, more specifically, on the second end 822 of the cam portion 82.

[0051] The indicator 8 is rotatably mounted on the adapter 1 around an axis of rotation that may be parallel or perpendicular to the longitudinal axis A of the adapter 1. Preferably, the indicator 8 is rotatably mounted on the adapter 1 around an axis of rotation that is parallel to the longitudinal axis A of the adapter 1. The cam portion 82 is thus preferably configured to be pushed radially outward by the connector when the connector reaches a predetermined position on the adapter 1. The adapter 1 comprises a pivot connection that rotatably connects the indicator 8 to the side wall 6 of the adapter 1. The indicator 8 thus forms a rotatable flap that closes the window 60 in a first position and opens the window 60 in a second position. As shown in Fig. 3 or 7, the axis of rotation may be located at a first end 826 of the cam portion 82, said cam portion 82 may have an apex 824 provided at a second end 822 opposite said first end 826. The adapter 1 may include biasing means configured to bias the indicator 8 towards the second open position such that the indicator 8 suddenly pops out to the second position when the connection is completed. As a result, indicator 8 in the second position may be in a stable equilibrium state, while indicator 8 in the first position may be in an unstable equilibrium state.

[0052] In a first embodiment shown in Figures 1-3 and 9, the indicator 8 and the adapter 1 are two different parts that are assembled together. The pivot connection may be formed by two ridges 12 engaged with two complementary shaped recesses 14. The ridges 12 or the recesses may be located in the indicator 8, while the recesses 14 or the ridges, respectively, may be located in the window 60.

[0053] In a second embodiment, shown in Figures 6-7 and 10, the indicator 8 and adapter 1 are molded in a single piece. The connection may be made by a resilient arm 86 that connects the indicator 8 to the side wall 6 of the adapter 1, more specifically within the window 60. The resilient arm 86 may form a biasing means for biasing the indicator 8 towards the second open position.

[0054] It is contemplated that the indicator 8 advantageously has a different color than the rest of the adapter 1, and more specifically, the color of the side wall 6 of the adapter 1. The adapter 1 may also be provided with an indicating surface that is hidden from the end user when the indicator 8 is in the first position and becomes visible to the end user when the indicator 8 is in the second position. This indicating surface may have a different color than the rest of the adapter 1, and more specifically, any surface that is visible to the end user when the indicator 8 is in the first position. For example, the indicating surface may be an inner surface 80a of the outer wall 80 of the indicator 8, or an edge surface 8a of the indicator 8, or an outer surface 61 of the side wall 6, said outer surface 61 being hidden by the indicator 8 in the first position.

[0055] The adapter 1 may be made of a plastic material, more precisely of any rigid polymer compatible with medical applications, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. Preferably, the adapter 1 is made of polycarbonate (PC). The indicator 8 may be made of the same material as the rest of the adapter 1, or of a different material, for example, between high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA), and combinations thereof. In the first embodiment shown in Figures 1-3 and 9, the indicator may preferably be made of polycarbonate (PC). In a second embodiment shown in Figures 4-7 and 10, the indicator may preferably be made of polypropylene (PP) or polyoxymethylene (POM).

[0056] With reference to Figures 8-10, the present invention also relates to a medical container 100 comprising a distal tip 102 and an adapter 1 having the above-mentioned features, said adapter 1 being mounted on the distal tip 102 of the medical container 100. The medical container 100 may be a syringe, such as a pre-fillable or pre-filled syringe, comprising a tubular barrel 104 defining a reservoir of a medical product. The tubular barrel 104 is provided with a distal tip 102 that may protrude from a distal shoulder 106. The distal tip 102 may be cylindrical or distally tapered. The distal tip 102 includes an internal passageway 108 in communication with the reservoir. The tubular barrel 104 and the distal tip 102 are preferably made of glass. The medical container 100 may comprise a piston and plunger rod (not shown) for expelling the medical product from the reservoir and through the passageway. The adapter 1 may be secured to the distal tip 102 by adhesive, threading, friction, or snap fitting.

[0057] 8, the medical container 100 may include a cap 110 having external threads 112 configured to engage with the internal threads 40 of the adapter 1 to secure the cap to the adapter 1. The cap 110 is configured to be secured to the adapter 1 without the external threads 112 of the cap 110 abutting the cam portion 82 of the indicator 8. Thus, the cap 110 may include a connecting portion 114 whose length is less than the distance between the distal end of the adapter 1 and the cam portion 82 of the indicator 8. Additionally, the cap 110 may include a proximal abutment surface 116 configured to abut the distal end of the adapter 1 such that the cap 110 cannot be further inserted into the adapter 1, thereby preventing the cap 110 from applying any pressure to the cam portion 82. The cap 110 may include an inner cap 118 made of a softer material than the cap to hermetically close the distal tip 102.

[0058] The use of the adapter 1 is described below with reference to Figures 1-2 or 4-6.

[0059] The user inserts the connector into the distal end of the adapter 1, engaging the wings 202 of the needle hub 200 with the internal threads 40 of the adapter 1. The user starts to screw the needle hub 200 into the adapter 1. When the needle hub 200 reaches the predetermined position, the wings 202 of the needle hub 200 start to abut the cam portion 82 of the indicator 8, said wings 202 exerting a radial pressure on said cam portion 82. However, due to the blocking means, the indicator 8 remains in the first position and does not open unless the radial force exerted by the needle hub 200 on the cam portion 82 is high enough. The user continues to screw the needle hub 200 into the adapter 1. The radial force exerted by the needle hub 200 thus increases until this force overcomes the action of the blocking means. The indicator 8 is thus moved towards the second position, making it visible to the end user that the needle hub 200 has reached the predetermined position. Thus, the connection is completed (FIGS. 2 and 6). In this position, the connection between the needle hub 200 and the adapter 1 is strong enough to allow the user to perform an injection operation without the risk of leakage. This position also prevents any over-threading that could lead to the user applying too high a threading torque and thus rotating the adapter 1 relative to the distal tip 102 and / or breaking the needle hub 200 and / or the adapter 1.

[0060] The invention also relates to a method for manufacturing an adapter 1 as described above, said method comprising the steps of: forming the indicator 8 by injection molding; forming the adapter 1 by injection molding.

[0061] With reference to the adapter 1 according to the first embodiment shown in Figures 1-3 and 9, the method may further comprise the step of assembling the indicator 8 and the side wall 6 of the adapter 1. For example, the indicator 8 is clipped to the side wall 6 of the adapter 1. More specifically, the ridge of the indicator 8 is placed in the recess of the window 60. Thus, the indicator 8 is rotatably mounted on the adapter 1 in a single simple step.

[0062] With reference to the adapter 1 according to the second embodiment shown in figures 4-7 and 10, the step of forming the indicator 8 and forming the adapter 1 is a single step of forming the indicator 8 and the remainder of the adapter 1 in the same injection mould. Thus, the adapter 1 and the indicator 8 can be of the same material or can be co-injection moulded to be made of two different materials. In this case, the material of the indicator 8 can be less rigid than the material forming the remainder of the adapter 1. Preferably, the indicator 8 and the adapter 1 are completely injection moulded with the indicator 8 in the second position, the normal shape of the indicator 8 being the second open position. In this second position, the elastic arm 86 is not deformed. The method comprises the further step of moving the indicator 8 to the first position until the blocking means is actuated, thus maintaining the indicator 8 in the first position against the spring action of the deformed elastic arm 86.

Claims

1. An adapter (1) for connecting a medical container (100) to a connector, comprising: a proximal portion (2) configured to be secured to a distal tip (102) of said medical container (100); a distal portion (4) configured to receive the connector to establish fluid communication between the distal tip (102) of the medical container (100) and the connector, the distal portion (4) including a window (60) extending through a side wall (6) of the adapter; an indicator (8) movable between a first position and a second position, the indicator extending outwardly relative to the first position; blocking means configured to block movement of the indicator (8) from the first position to the second position; a cam portion (82) protruding from the window (60) inside the adapter (1) in the first position, the cam portion (82) configured to be pushed outward by the connector when the connector reaches a predetermined position within the adapter (1), thereby unblocking and pushing the indicator (8) to the second position to provide a visual indication to an end user that a connection between the connector and the adapter (1) has been completed; an indicator (8) comprising The adapter (1) is provided with:

2. 2. The adapter (1) according to claim 1, wherein the blocking means comprises a protrusion (10) configured to abut an inner surface of the side wall (6) of the adapter or a gripping rib (64) of the adapter (1).

3. An adapter (1) according to any of claims 1-2, wherein the window (60) opens in a thread root (40b) of the internal thread (40) of the adapter (1).

4. An adapter (1) according to any one of claims 1 to 3, wherein the indicator (8) is rotatably connected to the side wall (6) of the adapter (1).

5. An adapter (1) as claimed in any one of claims 1 to 4, wherein the blocking means comprises a resilient leg (84) configured to be deformed and then released when the indicator (8) is pushed from the first position to the second position, thereby generating a sound.

6. The adapter (1) according to any one of claims 1 to 5, wherein the indicator (8) is attached to the adapter (1).

7. An adapter (1) as described in any of claims 1-6, wherein the indicator (8) is clipped to the adapter (1).

8. The adapter (1) according to any one of claims 1 to 4, wherein the indicator (8) and the adapter (1) are made in a single piece.

9. An adapter (1) as described in any of claims 1-4 or 8, wherein the indicator (8) is connected to the side wall (6) by a resilient arm (86), the resilient arm (86) configured to bias the indicator (8) towards the second position.

10. A medical container (100) comprising a distal tip (102) and an adapter (1) according to any one of claims 1-9, wherein the adapter (1) is attached to the distal tip (102) of the medical container (100).

11. 11. The medical container (100) of claim 10, comprising a cap having a connection portion that engages with the adapter (1), the connection portion configured to secure the cap to the adapter (1) without abutting the cam portion (82) of the indicator (8).

12. A method for manufacturing an adapter (1) according to any one of claims 1 to 9, comprising the steps of: forming an indicator (8) by injection molding; forming an adapter (1) by injection molding; and how to prepare.

13. The method according to claim 12, wherein the method further comprises the step of assembling the indicator (8) and the adapter (1).

14. 13. The method of claim 12, wherein the steps of forming the indicator (8) and forming the adapter (1) are a single step of forming the indicator (8) and the adapter (1) together in the same injection mold.

15. 15. The method of claim 14, wherein the indicator (8) is injection molded to be in the second position.

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